Funder: National Institutes of Health
Due Dates: May 17, 2025 (Letter of Intent) | June 16, 2025 (New) | July 16, 2025 (Renewal/Resubmission/Revision) | September 16, 2025 (Letter of Intent) | October 16, 2025 (New) | November 16, 2025 (Renewal/Resubmission/Revision) | January 17, 2026 (Letter of Intent) | February 16, 2026 (New) | March 16, 2026 (Renewal/Resubmission/Revision) | May 17, 2026 (Letter of Intent) | June 16, 2026 (New) | July 16, 2026 (Renewal/Resubmission/Revision)
Funding Amounts: Up to $450,000 direct costs over 3 years; no more than $225,000 direct costs in any single year.
Summary: Supports R34 clinical trials to develop, pilot, or plan research on improving treatment and recovery for alcohol use disorder (AUD), including medications, behavioral therapies, health services, and reducing disparities.
Key Information: Clinical trial required; only human studies are allowed; foreign organizations are eligible.
Description
This opportunity, offered by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) at NIH, supports R34 planning grants for clinical trials focused on alcohol treatment, pharmacotherapy, and recovery research. The goal is to close the treatment gap for individuals with alcohol use disorder (AUD) by supporting pilot or planning studies that will inform future, larger-scale clinical trials.
Research areas of interest include:
- Development and evaluation of new or repurposed medications for AUD
- Precision medicine and identification of predictors of treatment response
- Behavioral therapies and mechanisms of behavioral change (MOBC)
- Recovery processes, including risk/resilience factors and long-term outcomes
- Translational research applying neuroscience and genetics to treatment
- Innovative methods and technologies (e.g., digital health, telemedicine)
- Health services research, including access, cost, insurance, and implementation
- Reducing health disparities and improving care for underserved populations
Applications must propose a clinical trial in humans (no animal studies). Projects may include pilot studies, feasibility studies, or planning activities for future clinical trials.
Due Dates
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Letter of Intent (LOI):
- May 17, 2025 (for June 16, 2025 application)
- September 16, 2025 (for October 16, 2025 application)
- January 17, 2026 (for February 16, 2026 application)
- May 17, 2026 (for June 16, 2026 application)
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Application Deadlines:
- June 16, 2025 (New)
- July 16, 2025 (Renewal/Resubmission/Revision)
- October 16, 2025 (New)
- November 16, 2025 (Renewal/Resubmission/Revision)
- February 16, 2026 (New)
- March 16, 2026 (Renewal/Resubmission/Revision)
- June 16, 2026 (New)
- July 16, 2026 (Renewal/Resubmission/Revision)
All applications are due by 5:00 PM local time of the applicant organization.
Funding Amount
- Direct Costs: Up to $450,000 total over the project period (maximum 3 years)
- Annual Limit: No more than $225,000 in direct costs in any single year
- Project Period: Up to 3 years
The number of awards is contingent on NIH appropriations and the submission of a sufficient number of meritorious applications.
Eligibility
Eligible applicants include:
- Public and private institutions of higher education
- Nonprofits (with or without 501(c)(3) status)
- For-profit organizations (including small businesses)
- State, county, city, township, and special district governments
- Independent school districts
- Public housing authorities/Indian housing authorities
- Native American tribal governments and organizations (federally recognized and other)
- Faith-based and community-based organizations
- Regional organizations
- U.S. federal agencies and U.S. territories/possessions
- Foreign (non-U.S.) organizations and components
Key notes:
- Foreign organizations and non-domestic components of U.S. organizations are eligible.
- Multiple applications from the same organization are allowed if scientifically distinct.
- Individuals with the skills, knowledge, and resources necessary to carry out the proposed research are encouraged to apply.
Application Process
- Letter of Intent: Strongly encouraged but not required; submit 30 days before the application due date. Include project title, PI(s), key personnel, institutions, and funding opportunity number/title. Email to the scientific contact listed below.
- Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
- Application Forms: Use the SF424 (R&R) forms and follow the NIH How to Apply - Application Guide.
- Required Registrations: Applicant organizations must register with SAM, Grants.gov, and eRA Commons. PIs must have an eRA Commons account.
- Clinical Trial Requirements: Applications must propose a clinical trial in humans. See NIH clinical trial definition.
- Data Management and Sharing Plan: Required for all applications.
- Budget: Use the R&R Budget Form (not modular). Foreign organizations must use detailed budgets.
Additional Information
Research Areas Not Supported
Applications will not be considered responsive if they focus on:
- Preclinical animal studies
- HIV/AIDS-related studies
- Substances other than alcohol or polysubstance use disorders
- Prevention clinical trials
- Community setting trials (e.g., community centers, college campuses)
- Organ-associated diseases
- Basic experimental studies involving humans (BESH)
- Efficacy/dissemination of brief interventions for high-risk/understudied populations
- Indirect health behavior interventions (e.g., sleep, fitness)
- Social/environmental factors as primary drivers of drinking patterns
Review Criteria
Applications will be evaluated for:
- Significance and innovation
- Rigor and feasibility of the approach
- Investigator expertise and environment
- Protections for human subjects
- Budget and period of support
Data Sharing
All applications must include a Data Management and Sharing Plan in accordance with NIH policy.
External Links
Contact Information
For technical support with Grants.gov: support@grants.gov or 800-518-4726